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Benefit of Intensified Peri-operative Chemotherapy Within High-risk CINSARC Patients With Resectable Soft-tissue Sarcomas

ConditionsNon-metastatic Soft-tissue SarcomaResectable
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Bergonié

About this trial

The primary objective of this trial is to investigate whether the addition of 3 additional neo-adjuvant cycles of chemotherapy (doxorubicin based chemotherapy) to standard management according to the ISG-STS 10-01 study (3 cycles of neoadjuvant doxorubicin based chemotherapy + surgery +/- radiotherapy) improves the outcome of high-risk CINSARC patients with resectable soft-tissue sarcoma (STS). Primary endpoint is metastatic progression-free survival (M-PFS, after 3 years of follow-up).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed soft-tissue sarcoma by the RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) network, as recommended by the French NCI,

Grade 2 or 3 according to the FNCLCC grading system,

Available archived tumour sample for research purpose,

Non-metastatic and resectable disease,

Disqualifiers

Soft-tissue sarcoma with the following histological subtypes: well-differentiated liposarcoma, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clearcell sarcoma, embryonal and alveolar rhabdomyosarcoma,

Prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma,

Any other contraindication to anthracycline, ifosfamide or dacarbazine chemotherapy,

Participation to a study involving a medical or therapeutic intervention in the last 28 days,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Doxorubicin

    Drug

    A treatment cycle consists of 3 weeks. Doxorubicin will be administered from day 1 to day 3 (60 or 75mg/m² day or 20 or 25 mg/m² per day), repeated every 3 weeks, up to 3 cycles.

  • Ifosfamide or dacarbazine

    Drug

    A treatment cycle consists of 3 weeks. Treatment may continue up to 3 cycles. Ifosfamide will be administered from day 1 to day 3 (7,5-9 g/m² over 3 days with mesna and G-CSF) or dacarbazine (100 mg/m² 1 day or 450 mg/m² 2 days) as per local practices, repeated every 3 weeks, up to 3 cycles.

  • Doxorubicin

    Drug

    A treatment cycle consists of 3 weeks. Doxorubicin will be administered from day 1 to day 3 (60 or 75mg/m² day or 20 or 25 mg/m² per day), repeated every 3 weeks, up to 6 cycles.

  • Ifosfamide or dacarbazine

    Drug

    A treatment cycle consists of 3 weeks. Ifosfamide will be administered from day 1 to day 3 (7,5-9 g/m² over 3 days with mesna and G-CSF) or dacarbazine (100 mg/m² 1 day or 450 mg/m² 2 days) as per local practices, repeated every 3 weeks, up to 6 cycles.

  • At the discretion of the investigator

    Drug

    Drug at the discretion of the investigator.

Treatment groups

351 Participants
are divided into 3 treatment groups
Group A: Arm AExperimental treatment 2 interventions
Group B: Arm BExperimental treatment 2 interventions
Group C: Prospective cohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Metastasis progression-free survival in High-risk CINSARC patients

Metastasis progression-free survival (M-PFS) defined as the time interval between the date of randomization and the date of death or distant progression.

Time frame
3 years

Secondary outcomes

1

Loco-regional relapse-free survival in High-risk CINSARC patients

Loco-regional relapse-free survival (LR-RFS) defined as the time interval between the randomization date and the date of death or loco-regional progression.

Time frame
3 years
2

Progression-free survival in High-risk CINSARC patients

Progression-free survival (PFS) defined as the time interval between the randomization date and the date of death or progression (as per RECIST v1.1).

Time frame
3 years
3

Overall survival in High-risk CINSARC patients

Overall survival (OS) defined as the time interval between the randomization date and the date of death.

Time frame
3 years
4

Best overall response in High-risk CINSARC patients

Best overall response under treatment as per RECIST v1.1.

Time frame
Throughout the treatment period, an average of 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut Bergonié

Lead sponsor

Novartis

Collaborator

Chugai Pharma France

Collaborator

Source ClinicalTrials.gov
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